Beckman Coulter, Inc. is recalling approximately 498 units in the U.S. and 1,576 units internationally of the Access Erythropoietin (EPO) diagnostic test, catalog number A16364. This test is used by healthcare providers to measure erythropoietin, a hormone that regulates red blood cell production. One specific lot was found to produce results up to 22% lower than they should be, which could lead to an incorrect diagnosis or the need for repeat medical testing. No injuries or incidents have been reported to date.
The affected lot may provide repeatable falsely decreased results when testing patient samples. These inaccurate readings could cause healthcare providers to misinterpret a patient's health status, potentially leading to improper medical management or delayed treatment.
Stop using the recalled product.
Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared to alternate reagent lots.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.